BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK CELECT VENA CAVA FILTER

    MDR report key: 1051182 · Received May 22, 2008

    Report

    Report Number
    3002808486-2008-00004
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Report Date
    April 25, 2008
    Manufacturer
    WILLIAM COOK EUROPE, APS
    Product Code
    DTK
    PMA / PMN Number
    K061815
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: THIS EVENT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    THE VENA CAVA FILTER WAS PLACED INTO A MALE PATIENT IN 2008 FOR RECURRENT PE. DURING ATTEMPTED REMOVAL OF THE FILTER, THE SNARE SNAPPED IN THE PATIENT AND IT TOOK OVER 2 HOURS FOR FILTER REMOVAL. PATIENT EXPERIENCED PAIN AND CT SHOWS FILTER LEGS OUTSIDE THE VESSEL WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK CELECT VENA CAVA FILTER DTK VENA CAVA FILTER DTK WILLIAM COOK EUROPE, APS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR